The ICH Q9 Guideline, originally issued in 2005, underwent a targeted revision and was republished as ICH Q9(R1) in 2023. This revision addressed four key areas for improvement in the application of Quality Risk Management (QRM):
- High levels of subjectivity in risk assessments and QRM outputs
- Inadequate management of supply and product availability risks
- Lack of understanding of what constitutes formality in QRM
- Unclear guidance on risk-based decision-making
Additionally, two further points were identified for clarification:
- Expectations for maintaining current risk assessments and implementing risk review activities
- Updating the term “risk identification” to the more accurate term “hazard identification”

This workshop will focus on the practical implementation of ICH Q9(R1). We will begin with a presentation from Dr. Kevin O’Donnell, HPRA & ICH Q9(R1) Rapporteur, providing regulatory insights and expectations on the implementation. A key focus area will be on reducing subjectivity in risk assessments and enhancing best practices in risk-based decision-making, using ICH Q9(R1) training materials as a foundation.
Through interactive polls, Q&A sessions, and discussions, we will engage participants on key concerns and challenges. Additionally, we will explore case studies, including applications of new technologies and artificial intelligence, and outline a recommended roadmap for successful ICH Q9(R1) implementation and improvement. These insights will help advance industry adoption of QRM to support sustained manufacturing excellence and defect reduction.
This practical workshop is particularly valuable for QA and Regulatory professionals, offering direct engagement with Regulatory insights and industry case studies. However, individuals from all discipline across the organization will benefit from the practical consideration of how QRM must be implemented across the PQS.

Arie Menachem

VP, Quality Audits & Inspections, Novo Nordisk

Appearances